🇺🇸 Mounjaro in United States

FDA authorised Mounjaro on 13 May 2022 · 61,729 US adverse-event reports

Marketing authorisations

FDA — authorised 13 May 2022

  • Application: NDA215866
  • Marketing authorisation holder: ELI LILLY AND CO
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Incorrect Dose Administered — 15,979 reports (25.89%)
  2. Injection Site Pain — 8,513 reports (13.79%)
  3. Nausea — 7,979 reports (12.93%)
  4. Off Label Use — 7,059 reports (11.44%)
  5. Extra Dose Administered — 4,760 reports (7.71%)
  6. Diarrhoea — 4,609 reports (7.47%)
  7. Vomiting — 3,944 reports (6.39%)
  8. Injection Site Haemorrhage — 3,309 reports (5.36%)
  9. Constipation — 2,798 reports (4.53%)
  10. Injection Site Erythema — 2,779 reports (4.5%)

Source database →

Mounjaro in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in United States

Frequently asked questions

Is Mounjaro approved in United States?

Yes. FDA authorised it on 13 May 2022; FDA has authorised it.

Who is the marketing authorisation holder for Mounjaro in United States?

ELI LILLY AND CO holds the US marketing authorisation.